BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY CEMENTED NARROW FEMUR SIZE 4 RIGHT

    MDR report key: 5252969 · Received November 27, 2015

    Report

    Report Number
    3005180920-2015-00296
    Event Type
    Injury
    Date Received
    November 27, 2015
    Date of Event
    October 30, 2015
    Report Date
    February 24, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 27 JANUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 02 FEBRUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 23RD 2015: THE SALES AGENT THOUGHT HE WAS GOING TO GET THE X-RAYS BUT WAS UNABLE TOO. THE REVISION SURGERY WAS DUE TO A SUSPECTED INFECTION. THE PATHOLOGY RESULTS WILL NOT BE AVAILABLE. BATCH REVIEW PERFORMED ON 27 NOVEMBER 2015: LOT 148556: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MARCH 2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED # 3 R CODE 02.07.1203R LOT. 148725 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MARCH 2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. GMK-PRIMARY PATELLA RESURFACING # 2 CODE 02.07.0034RP LOT. 150322 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 MAY 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. GMK-PRIMARY TIBIAL INSERT PS FIXED # 3/12MM CODE 02.07.0312PSF LOT. 131858 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JULY 2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. GMK-PRIMARY EXTENSION STEM Ø11MM / L 30 MM CODE 02.07.F11030 LOT. 151567 (K133630): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Description of Event or Problem · 1

    PATIENT CAME IN COMPLAINING OF PAIN IN HER RIGHT KNEE. THE SURGEON REMOVED ALL COMPONENTS AND PUT IN GMK REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE EXPLANTS WILL NOT BE AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783053 GMK PRIMARY CEMENTED NARROW FEMUR SIZE 4 RIGHT CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 148556

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention